RTI Surgical today announced it received investigational device exemption approval from the FDA to study its Cortiva Allograft Dermis.
The Alachua, Florida-based company plans to initiate a study to confirm the safety and effectiveness of Cortiva in implant-based breast reconstruction.
Cortiva is processed using the Tutoplast tissue sterilization process and the implants are currently regulated as Section 361 human cell and tissue products. They are restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue.
“This milestone marks a significant step towards obtaining FDA pre-market approval (PMA) for our Cortiva allograft implants. It reinforces our strategic objective of becoming a leading medical device company in regenerative medicine by offering a diverse portfolio that enables surgeons to better address the unique needs of their patients,” President and CEO Olivier Visa said in a news release.
In consultation with the FDA, RTI Surgical has developed a clinical study to support a pre-market approval application to get an indication for Cortiva’s use in breast reconstruction. Patient enrollment in the study is scheduled to begin in the first half of 2024 across the U.S.